Detailed understanding of longitudinal behavior, response to therapy, and applicable biomarkers for interstitial lung diseases (ILDs) is lacking. There is a need for a large multicenter registry that provides researchers and clinicians access to well-characterized data not limited to patients with idiopathic pulmonary fibrosis. The Pulmonary Fibrosis Foundation Patient Registry (PFF-PR) is a database that collects baseline and longitudinal demographic and clinical information about patients with ILDs in the United States. The objective of this study is to describe the patient population, data collection process, and opportunities for retrospective and prospective research with the PFF-PR. Individuals 18 years or older who had ILD diagnosed and who were seen at PFF-PR centers who provided informed consent were eligible to participate. Baseline and longitudinal demographic, spirometric, radiographic, morbidity, and mortality data are recorded into a secure electronic data capture system. Starting in 2016, the PFF-PR has collected data on 2,003 patients at 42 clinical sites in the United States. At the time of enrollment, the mean age of participants was 68 years old. Most (62%) of participants were male, and 58% had a positive smoking history. The mean forced vital capacity was 69% predicted, and the mean diffusing capacity of the lung for carbon monoxide was 43% predicted. Forty-one percent of patients were using supplemental oxygen, and 39% were on antifibrotic therapy. Reasons for attrition were mostly death or transplant, with low rates of loss to follow-up or withdrawal. The PFF-PR is a large multicenter United States-based registry that provides researchers and clinicians access to well-characterized ILD patient data.

Medicaid beneficiaries in 6 North Carolina counties were randomly assigned to 1 of 3 clinical decision support (CDS) care transition strategies: (1) usual care (Control), (2) CDS messaging to patients and their medical homes (Reports), or (3) CDS messaging to patients, their medical homes, and their care managers (Reports+). We included 7146 Medicaid patients and evaluated transitions from specialist visit, ER and hospital encounters back to the patient's medical home. Patients enrolled in Medicare and Medicaid were not eligible. The number of care manager contacts was greater for patients in the Reports+ Group than in the Control Group. However, there were no treatment-related differences in emergency department (ED) encounter rates, or in the secondary outcomes of outpatient and hospital encounter rates and medical costs. Study monitors found study intervention documentation in approximately 60% of patient charts. These results highlight the importance of effectively integrating information interventions into healthcare delivery workflow systems.

Background— The impact of patient age on the risks of death or rehospitalization after primary prevention implantable cardioverter-defibrillator (ICD) placement is uncertain. Methods and Results— Data from 5 major ICD trials were merged: the Multicenter Automatic Defibrillator Implantation Trial I (MADIT-I), the Multicenter UnSustained Tachycardia Trial (MUSTT), the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II), the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation Trial (DEFINITE), and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Median age at enrollment was 62 (interquartile range 53–70) years. Compared with their younger counterparts, older patients had a greater burden of comorbid illness. In unadjusted exploratory analyses, ICD recipients were less likely to die than nonrecipients in all age groups: among patients aged <55 years: hazard ratio 0.48, 95% posterior credible interval 0.33 to 0.69; among patients aged 55 to 64 years: hazard ratio 0.69, 95% posterior credible interval 0.53 to 0.90; among patients aged 65 to 74 years: hazard ratio 0.67, 95% posterior credible interval, 0.53 to 0.85; and among patients aged ≥75 years: hazard ratio 0.54, 95% posterior credible interval 0.37 to 0.78. Sample sizes were limited among patients aged ≥75 years. In adjusted Bayesian–Weibull modeling, point estimates indicate ICD efficacy persists but is attenuated with increasing age. There was evidence of an interaction between age and ICD treatment on survival (two-sided posterior tail probability of no interaction <0.01). Using an adjusted Bayesian logistic regression model, there was no evidence of an interaction between age and ICD treatment on rehospitalization (two-sided posterior tail probability of no interaction 0.44). Conclusions— In this analysis, the survival benefit of the ICD exists but is attenuated with increasing age. The latter finding may be because of the higher burden of comorbid illness, competing causes of death, or limited sample size of older patients. There was no evidence that age modifies the association between ICD treatment and rehospitalization.

Several randomized clinical trials have shown that the implantable cardioverter defibrillator (ICD) improves the survival of patients with systolic heart failure due to ischemic or non-ischemic cardiomyopathy [ 1 Moss A.J. Hall W.J. Cannom D.S. et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med. 1996; 335: 1933-1940 Crossref PubMed Scopus (3532) Google Scholar , 2 Buxton A.E. Lee K.L. Fisher J.D. et al. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med. 1999; 341: 1882-1890 Crossref PubMed Scopus (2189) Google Scholar , 3 Moss A.J. Zareba W. Hall W.J. et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002; 346: 877-883 Crossref PubMed Scopus (5545) Google Scholar , 4 Kadish A. Dyer A. Daubert J.P. et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004; 350: 2151-2158 Crossref PubMed Scopus (1627) Google Scholar , 5 Bardy G.H. Lee K.L. Mark D.B. et al. Amiodarone or an implantable cardioverter–defibrillator for congestive heart failure. N Engl J Med. 2005; 352: 225-237 Crossref PubMed Scopus (5227) Google Scholar ]. Although most of these trials required a left ventricular ejection fraction (LVEF) of ≤35%, the median LVEF of enrolled patients was well below 30% [ 1 Moss A.J. Hall W.J. Cannom D.S. et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med. 1996; 335: 1933-1940 Crossref PubMed Scopus (3532) Google Scholar , 2 Buxton A.E. Lee K.L. Fisher J.D. et al. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med. 1999; 341: 1882-1890 Crossref PubMed Scopus (2189) Google Scholar , 3 Moss A.J. Zareba W. Hall W.J. et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002; 346: 877-883 Crossref PubMed Scopus (5545) Google Scholar , 4 Kadish A. Dyer A. Daubert J.P. et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004; 350: 2151-2158 Crossref PubMed Scopus (1627) Google Scholar , 5 Bardy G.H. Lee K.L. Mark D.B. et al. Amiodarone or an implantable cardioverter–defibrillator for congestive heart failure. N Engl J Med. 2005; 352: 225-237 Crossref PubMed Scopus (5227) Google Scholar ]. This is why when the United States' government mandated a national ICD registry to collect data on primary prevention ICDs in patients ≥65 years of age, they designated patients with LVEF between 30% and 35% as an important subgroup in need of more data on ICD effectiveness [ 6 Hammill S.C. Stevenson L.W. Kadish A.H. et al. National ICD Registry Annual Report 2006: review of the registry's first year, data collected, and future plans. Heart Rhythm. 2007; 4: 1260-1263 Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar , 7 Kremers M.S. Hammill S.C. Berul C.I. et al. National ICD registry report: version 2.1 including leads and pediatrics for years 2010 and 2011. Heart Rhythm. 2013; 10: e59-e65 Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar ]. Using a merged database of randomized clinical trials of ICDs, we sought to characterize patients with LVEF between 30% and 35% and to compare their outcomes with those of patients with LVEF <30%.

BACKGROUND:Enhanced recovery after surgery (ERAS) is a multimodal approach to perioperative care that combines a range of interventions to enable early mobilization and feeding after surgery. We investigated the feasibility, clinical effectiveness, and cost savings of an ERAS program at a major U. S. teaching hospital. METHODS:Data were collected from consecutive patients undergoing open or laparoscopic colorectal surgery during 2 time periods, before and after implementation of an ERAS protocol. Data collected included patient demographics, operative, and perioperative surgical and anesthesia data, need for analgesics, complications, inpatient medical costs, and 30-day readmission rates. RESULTS:There were 99 patients in the traditional care group, and 142 in the ERAS group. The median length of stay (LOS) was 5 days in the ERAS group compared with 7 days in the traditional group (P < 0.001). The reduction in LOS was significant for both open procedures (median 6 vs 7 days, P = 0.01), and laparoscopic procedures (4 vs 6 days, P < 0.0001). ERAS patients had fewer urinary tract infections (13% vs 24%, P = 0.03). Readmission rates were lower in ERAS patients (9.8% vs 20.2%, P = 0.02). DISCUSSION:Implementation of an enhanced recovery protocol for colorectal surgery at a tertiary medical center was associated with a significantly reduced LOS and incidence of urinary tract infection. This is consistent with that of other studies in the literature and suggests that enhanced recovery programs could be implemented successfully and should be considered in U.S. hospitals.

The aim of this study was to determine if the benefit of implantable cardioverter-defibrillators (ICDs) is modulated by medical comorbidity. Primary prevention ICDs improve survival in patients at risk for sudden cardiac death. Their benefit in patients with significant comorbid illness has not been demonstrated. Original, patient-level datasets from MADIT I (Multicenter Automatic Defibrillator Implantation Trial I), MADIT II, DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation), and SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) were combined. Patients in the combined population (N = 3,348) were assessed with respect to the following comorbidities: smoking, pulmonary disease, diabetes, peripheral vascular disease, atrial fibrillation, ischemic heart disease, and chronic kidney disease. The primary outcome was overall mortality, using the hazard ratio (HR) of time to death for patients receiving an ICD versus no ICD by extent of medical comorbidity, and adjusted for age, sex, race, left ventricular ejection fraction, use of antiarrhythmic drugs, beta-blockers, and angiotensin-converting enzyme inhibitors. Overall, 25% of patients (n = 830) had <2 comorbid conditions versus 75% (n = 2,518) with significant comorbidity (≥2). The unadjusted hazard of death for patients with an ICD versus no ICD was significantly lower, but this effect was less for patients with ≥2 comorbidities (unadjusted HR: 0.71; 95% confidence interval: 0.61 to 0.84) compared with those with <2 comorbidities (unadjusted HR: 0.59; 95% confidence interval: 0.40 to 0.87). After adjustment, the benefit of an ICD decreased with increasing number of comorbidities (p = 0.004). Patients with extensive comorbid medical illnesses may experience less benefit from primary prevention ICDs than those with less comorbidity; implantation should be carefully considered in sick patients. Further study of ICDs in medically complex patients is warranted.

BACKGROUNDThe benefit of a primary prevention implantable cardioverter-defibrillator (ICD) among patients with chronic kidney disease is uncertain.STUDY DESIGNMeta-analysis of patient-level data from randomized controlled trials.SETTING & POPULATIONPatients with symptomatic heart failure and left ventricular ejection fraction<35%.SELECTION CRITERIA FOR STUDIESFrom 7 available randomized controlled studies with patient-level data, we selected studies with available data for important covariates. Studies without patient-level data for baseline estimated glomerular filtration rate (eGFR) were excluded.INTERVENTIONPrimary prevention ICD versus usual care effect modification by eGFR.OUTCOMESMortality, rehospitalizations, and effect modification by eGFR.RESULTSWe included data from the Multicenter Automatic Defibrillator Implantation Trial I (MADIT-I), MADIT-II, and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). 2,867 patients were included; 36.3% had eGFR<60 mL/min/1.73m2. Kaplan-Meier estimate of the probability of death during follow-up was 43.3% for 1,334 patients receiving usual care and 35.8% for 1,533 ICD recipients. After adjustment for baseline differences, there was evidence that the survival benefit of ICDs in comparison to usual care depends on eGFR (posterior probability for null interaction P<0.001). The ICD was associated with survival benefit for patients with eGFR≥60 mL/min/1.73 m2 (adjusted HR, 0.49; 95% posterior credible interval, 0.24-0.95), but not for patients with eGFR<60 mL/min/1.73 m2 (adjusted HR, 0.80; 95% posterior credible interval, 0.40-1.53). eGFR did not modify the association between the ICD and rehospitalizations.LIMITATIONSFew patients with eGFR<30 mL/min/1.73 m2 were available. Differences in trial-to-trial measurement techniques may lead to residual confounding.CONCLUSIONSReductions in baseline eGFR decrease the survival benefit associated with the ICD. These findings should be confirmed by additional studies specifically targeting patients with varying eGFRs.

OBJECTIVES:The aim of this study was to determine if the benefit of implantable cardioverter-defibrillators (ICDs) is modulated by medical comorbidity. BACKGROUND:Primary prevention ICDs improve survival in patients at risk for sudden cardiac death. Their benefit in patients with significant comorbid illness has not been demonstrated. METHODS:Original, patient-level datasets from MADIT I (Multicenter Automatic Defibrillator Implantation Trial I), MADIT II, DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation), and SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) were combined. Patients in the combined population (N = 3,348) were assessed with respect to the following comorbidities: smoking, pulmonary disease, diabetes, peripheral vascular disease, atrial fibrillation, ischemic heart disease, and chronic kidney disease. The primary outcome was overall mortality, using the hazard ratio (HR) of time to death for patients receiving an ICD versus no ICD by extent of medical comorbidity, and adjusted for age, sex, race, left ventricular ejection fraction, use of antiarrhythmic drugs, beta-blockers, and angiotensin-converting enzyme inhibitors. RESULTS:Overall, 25% of patients (n = 830) had <2 comorbid conditions versus 75% (n = 2,518) with significant comorbidity (≥2). The unadjusted hazard of death for patients with an ICD versus no ICD was significantly lower, but this effect was less for patients with ≥2 comorbidities (unadjusted HR: 0.71; 95% confidence interval: 0.61 to 0.84) compared with those with <2 comorbidities (unadjusted HR: 0.59; 95% confidence interval: 0.40 to 0.87). After adjustment, the benefit of an ICD decreased with increasing number of comorbidities (p = 0.004). CONCLUSIONS:Patients with extensive comorbid medical illnesses may experience less benefit from primary prevention ICDs than those with less comorbidity; implantation should be carefully considered in sick patients. Further study of ICDs in medically complex patients is warranted.

The benefit of primary prevention ICD among patients with CKD is uncertain. We conducted a meta analysis using patient-level data from 3 randomized controlled trials of ICDs to assess whether estimated glomerular filtration rate (eGFR) modifies the association between ICD treatment and mortality,

Background: The Positive Impact of EndoVascular Options for Treating Aneurysms Early (PIVOTAL) trial enrolled individuals with small (4.0- to 5.0-cm diameter) abdominal aortic aneurysms (AAA) and reported no difference in rupture or aneurysm-related death for patients who received early endovascular repair (EVAR) vs surveillance with serial imaging studies. We evaluated resource use, medical cost, and quality of life outcomes associated with the PIVOTAL treatment strategies.Methods: This prospective economic and quality of life study was conducted within a randomized trial, with PIVOTAL sites participating in the quality of life (n = 67) and economic (n = 63) studies. The PIVOTAL trial randomized 728 patients (366 early EVAR and 362 surveillance). We used information from 701 quality of life (351 early EVAR and 350 surveillance) and 614 economic (314 early EVAR and 300 surveillance) study participants enrolled in the PIVOTAL trial. The main outcome measures were total medical costs and the aneurysm repair rate at 48 months.Results: After 6 months, the rate of aneurysm repair was 96 vs 10 per 100 patients in the early EVAR and surveillance groups, respectively (difference, 86; 95% confidence interval [CI], 82-90; P < .0001), and total medical costs were greater in the early EVAR group ($33,471 vs $5520; difference, $27,951; 95% CI, $25,156-$30,746; P < .0001). In months 7 through 48, however, the rate of aneurysm repair was 54 per 100 patients in the surveillance group, and total medical costs were higher for patients in the surveillance vs the early EVAR group ($40,592 vs $15,197; difference, $25,394; 95% CI, $15,184-$35,605; P < .0001). At 48 months' follow-up, early EVAR patients had greater cumulative use of AAA repair (97 vs 64 per 100 patients; difference, 34; 95% CI, 21-46; P < .0001), but there was no difference in total medical costs ($48,669 vs $46,112; difference, $2557; 95% CI, -$8043 to $13,156; P = .64). After discounting at 3% per annum, total medical costs for early EVAR and surveillance patients remained similar ($47,765 vs $43,532; difference, 4232; 95% CI, -$5561 to $14,025; P = .40). There were no treatment-related differences in quality of life at 24 months.Conclusions: A treatment strategy involving early repair of smaller AAA with EVAR is associated with no difference in total medical costs at 48 months vs surveillance with serial imaging studies. Longer follow-up is required to determine whether the late medical cost increases observed for surveillance will persist beyond 48 months.

Although evidence-based pharmacotherapies are a principal component of patient care, 30-50% of patients do not take their medications as prescribed. We conducted a randomized trial of two clinical decision support (CDS) interventions in 2219 patients: patient adherence reports to providers (n=744), patient adherence reports to providers + email notices to care managers (n=736), and controls (739). At 18-month follow-up, there were no treatment-related differences in patient medication adherence (overall, by medication class, and by medical condition). There also were no treatment-related differences in patient clinical and economic outcomes. Thus, while this study's CDS information interventions were successfully delivered to providers and care managers, and were effective in identifying medication adherence deficits and in increasing care manager responses to medication adherences issues, these interventions were not able to alter patient medication behavior.

To determine whether a clinical decision support system can favorably impact the delivery of emergency department and hospital services. Randomized clinical trial of three clinical decision support delivery modalities: email messages to care managers (email), printed reports to clinic administrators (report) and letters to patients (letter) conducted among 20,180 Medicaid beneficiaries in Durham County, North Carolina with follow-up through 9 months. Patients in the email group had fewer low-severity emergency department encounters vs. controls (8.1 vs. 10.6/100 enrollees, p < 0.001) with no increase in outpatient encounters or medical costs. Patients in the letter group had more outpatient encounters and greater outpatient and total medical costs. There were no treatment-related differences for patients in the reports group. Among patients <18 years, those in the email group had fewer low severity (7.6 vs. 10.6/100 enrollees, p < 0.001) and total emergency department encounters (18.3 vs. 23.5/100 enrollees, p < 0.001), and lower emergency department ($63 vs. $89, p = 0.002) and total medical costs ($1,736 vs. $2,207, p = 0.009). Patients who were ≥18 years in the letter group had greater outpatient medical costs. There were no intervention-related differences in patient-reported assessments of quality of life and medical care received. The effectiveness of clinical decision support messaging depended upon the delivery modality and patient age. Health IT interventions must be carefully evaluated to ensure that the resultant outcomes are aligned with expectations as interventions can have differing effects on clinical and economic outcomes.

BACKGROUND:Whether there is an optimal time to place an implantable cardioverter-defibrillator (ICD) more than 40 days after myocardial infarction (MI) in guideline-eligible patients is unknown.OBJECTIVE:To evaluate the effect of time from MI to randomization on mortality, rehospitalizations, and complications.METHODS:Individual data on patients enrolled in 9 primary prevention ICD trials were provided. Clinical trials were eligible for the current analysis if they enrolled patients with an MI more than 40 days prior to randomization to primary prevention ICD therapy vs usual care: Multicenter Automatic Defibrillator Implantation Trial I, Multicenter UnSustained Tachyardia Trial, Multicenter Automatic Defibrillator Implantation Trial II, and Sudden Cardiac Death in Heart Failure Trial.RESULTS:ICD recipients died less frequently than nonrecipients at 5 years across all subgroups of time from MI to randomization. In unadjusted Cox proportional hazards regression, a survival benefit was evident in most subgroups. Adjusted Bayesian Weibull survival modeling yielded hazard ratio (HR) 0.50, 95% posterior credible interval (PCI) 0.20-1.25 41-180 days after MI; HR 0.98, 95% PCI 0.37-2.37 181-365 days after MI; HR 0.22, 95% PCI 0.07-0.59>1-2 years after MI; HR 0.42, 95% PCI 0.17-0.90>2-5 years after MI; HR 0.55, 95% PCI 0.25-1.15>5-10 years after MI; and HR 0.48, 95% PCI 0.20-1.02>10 years after MI. There was no evidence of an interaction between time from MI and all-cause mortality, rehospitalizations, or complications.CONCLUSIONS:In this meta-analysis, there was scant evidence that the efficacy of primary prevention ICD therapy depends on time to implantation more than 40 days after MI. Similarly, there was no evidence that the risks of rehospitalizations or complications depend on time more than 40 days after MI.

Governments are investing in health information technologies (HIT) to improve care quality and reduce medical costs. However, evidence of these benefits is limited. We conducted a randomized trial of three clinical decision support (CDS) interventions in 20,180 patients: email to care managers (n=3329), reports to primary care administrators (n=3368), letters to patients (n=3401), and controls (10,082). At 7-month follow-up, the letters to patients group had greater use of outpatient services and higher outpatient and total medical costs; whereas, the other groups had no change in clinical events or medical costs. As our CDS interventions were associated with no change or an increase in medical costs, it appears that investments in HIT without consideration for organizational context may not be sufficient to achieve improvements in clinical and economic outcomes.

BACKGROUND:Replication studies evaluate technologies in usual use settings.METHODS:We conducted a clinical trial to determine whether reductions in clinical and economic results observed in a previous study could be replicated in a larger setting. Subjects were randomized to receive intervention (email notifications for sentinel health events sent to their care managers) or control.MAIN OUTCOME MEASURES:The primary outcome was the rate of emergency department visits for low severity conditions. Secondary outcomes included: medical costs and other clinical event rates.RESULTS:We randomized 13,454 individuals (intervention, 6740; control, 6714). Subjects in both groups had similar rates of clinical events and medical costs.CONCLUSION:The use of email notifications to care managers was associated with no reductions in clinical events or medical costs.